FDA Recalls NDC 0487-9501 Albuterol Sulfate
Solution Respiratory (inhalation)

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Albuterol Sulfate with NDC 0487-9501 was initiated on 04-13-2022 as a Class II recall due to cgmp deviations: temperature abuse The latest recall number for this product is D-1020-2022 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1020-202204-13-202206-15-2022Class II96 pouchesAlbuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG by: Nephron Pharma, NDC 0487-9501-25Ongoing
D-1019-202204-13-202206-15-2022Class II23 pouchesAlbuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03Ongoing
D-66462-00110-02-201310-30-2013Class II689,568 cartonsAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25Terminated
D-1446-201206-22-201108-15-2012Class II56,028 cartonsAlbuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.